CASSIOPEIA Cervical Plate System 3311-0018

GUDID 08806395494118

The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The MVP Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136) The MVP Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (including fracture or dislocation), Spinal stenosis, Deformities or curvatures (kyphosis, lordosis, or scoliosis), Tumors, Pseudoarthrosis and Failed previous fusion.

GS Medical Co., Ltd.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08806395494118
• NIH Device Record Key: 08c3fd21-a93b-4339-ba58-5edc118ea23c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CASSIOPEIA Cervical Plate System
• Version Model Number: 3311-0018
• Catalog Number: 3311-0018
• Company DUNS: 688385418
• Company Name: GS Medical Co., Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806395494118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190170

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08806395494118]

Moist Heat or Steam Sterilization

[08806395494118]

Moist Heat or Steam Sterilization

[08806395494118]

Moist Heat or Steam Sterilization

[08806395494118]

Moist Heat or Steam Sterilization

[08806395494118]

Moist Heat or Steam Sterilization

[08806395494118]

Moist Heat or Steam Sterilization

[08806395494118]

Moist Heat or Steam Sterilization

[08806395494118]

Moist Heat or Steam Sterilization

[08806395494118]

Moist Heat or Steam Sterilization

[08806395494118]

Moist Heat or Steam Sterilization

[08806395494118]

Moist Heat or Steam Sterilization

[08806395494118]

Moist Heat or Steam Sterilization

[08806395494118]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-09-18
• Device Publish Date: 2019-06-18

On-Brand Devices [CASSIOPEIA Cervical Plate System]

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